A new bipartisan committee’s working group will gather on Capitol Hill throughout the coming months to find ways to improve electronic health records, according to Senate health committee chairman Lamar Alexander (R-Tenn.) and ranking member Patty Murray (D-Wash.).

The group will work to find five or six ways to “make the failed promise of electronic health records something that physicians and providers look forward to instead of something they endure,” Murray said in an announcement.

All members of the Senate health committee are invited to be a part of the working group. Staff meetings begin this week, with participation from health IT professionals, industry experts and government agencies.

The working group’s goals include the following:

Help providers improve quality of care and patient safety.

Facilitate interoperability between EHR vendors.

Empower patients to engage in their own care through access to their health data.

Protect privacy and security of health information.

The working group isn’t the only way Alexander and Murray are pushing for change when it comes to EHRs.

The Government Accountability Office placed the Veterans Affairs Department’s healthcare system on a list of high-risk programs for 2015, saying at an April 29 Senate Veterans’ Affairs Committee hearing that the agency needs to address inadequate oversight and ambiguous policies.

“Risks to the timeliness, costeffectiveness, quality and safety of veterans’ healthcare, along with other persistent weaknesses GAO and others have identified in recent years, raised serious concerns about VA’s management and oversight of its healthcare system,” said GAO Healthcare Director Debra Draper at the hearing.

GAO prepared testimony (pdf) says VA operates one of the largest healthcare delivery systems in the nation, including 150 medical centers and more than 800 community-based outpatient clinics.

Enrollment in the VA healthcare system has grown significantly, increasing from 6.8 to 8.9 million veterans between fiscal years 2002 and 2013, GAO says.

Over this same period, Congress has provided steady increases in VA’s healthcare budget, increasing from $23.0 billion to $55.5 billion.

At the hearing Draper outlined five major areas that put the VA at risk of failing to provide adequate healthcare to veterans including ambiguous policies and inconsistent processes, inadequate oversight and accountability, information technology challenges, inadequate training for VA staff and unclear resource needs and allocation priorities.

John Daigh, the VA’s assistant inspector general, agreed with Draper’s assessment of the Veterans Health Administration.

“VHA is at risk of not performing its mission as the result of several intersecting factors,” Deigh said. “VHA has several missions, and too often management decisions compromise the most important mission of providing veterans with quality healthcare.”

Daigh focused on the Veterans Integrated Service Networks – regional offices that are set up to oversees VA medical centers in certain areas – saying the current VISN structure has not worked effectively to support and solve problems facing hospitals.

One role of the VISNs is to make sure medical providers at each facility are doing their job properly with periodic reviews.

Daigh said in prepared testimony (pdf) that a forthcoming VA OIG report found that in hospitals where there are specialty units with small numbers of providers, it is difficult to obtain unbiased peer reviews of clinical cases and assessments of clinical performance by peers.

That lack of data makes it difficult for VISN’ to accurately assess medical care providers. But medical centers shouldn’t be shouldering all of the blame, Daigh said.

“The VISN structure has been inconsistently effective in addressing this issue,” he said.

Each VISN has a different internal organization and each medical facility has a different internal structure.

“This lack of standardization makes the dissemination of information and policy to facilities challenging and the acquisition of critical data from facilities more difficult,” Daigh said.

For more:
– go to the hearing page (webcast and prepared testimony available)

Should drug makers be required to disclose their costs to justify rising prices?

This is what a growing number of state legislatures are considering. Over the past several weeks, lawmakers in a handful of states stretching from California to Massachusetts have introduced bills in a bid to force the pharmaceutical industry to conduct an economic striptease.

“We need to have some transparency,” says Tony DeLuca, a Democrat who chairs the Pennsylvania House Insurance Committee and who introduced one such bill earlier this week. “Some of the sticker prices are outrageous. I’m hoping it achieves lower health care costs.”

The bills are not wholly identical. Some would require drug makers to report profits and various operational costs for any medicine that has a price tag of more than $10,000 a year, while others seek this information for all medicines, regardless of price. A bill was also introduced in North Carolina.

The effort comes as a national debate intensifies over prices for prescription medicines. Over the past year, payers – both public and private – have remonstrated over the cost of new specialty drugs for hard-to-treat ailments and for older generic drugs that were supposed to offer low-cost alternatives.

A new poll by the Kaiser Family Foundation found that 76% of Americans overall – and across party lines – say their top health care priority is ensuring that high-cost drugs for chronic conditions, such as HIV, hepatitis, mental illness and cancer, are affordable.

The issue is placing drug makers on the defensive, even as they argue pricey new medicines – notably, those for combating hepatitis C and certain rare diseases – represent good value for illnesses that would, otherwise, cost more to treat in the long run.

These bills represent a new front, though, in trying to blunt escalating price tags. And the legislation is winning enthusiastic backing from business groups, consumers advocates and health insurers, which some legislators say have helped craft language.

“This is about starting a conversation,” says Charles Bacchi, chief executive at the California Association Plans, which worked with a California legislator on one bill. “We need real answers about why these drugs are priced so high. Yes, there are limits to what a state can do, but it’s a debate we need to have.”

To what extent these bills may succeed is uncertain, at best.

Drug makers, not surprisingly, are pushing back and recently helped defeat legislation in Oregon. Earlier this week, the pharmaceutical industry trade group testified against the bill in California, where a vote was postponed until next week in light of opposition, according to a legislative aide.

As far as drug makers are concerned, the bills are not only onerous, but make demands they maintain cannot be met. For instance, an industry trade group argues that providing development costs for some drugs may be impossible when research was simultaneously conducted on other medicines that failed. The bottom line, says the California Healthcare Institute, is that the bill would “stifle innovation.”

“The price charged for an individual drug is not a reflection of development costs,” says Ken Kaitin, director of the Tufts Center for the Study of Drug Development, which receives pharmaceutical industry backing. “Pricing strategies are based on therapeutic value, market size, usage, patent life, competition and other factors.”

Even if one or more bills were to become law, there is no certain path toward lowering prices. But the effort may resonate around the country, especially with the 2016 presidential campaign under way. “This may be a model that other governments may want to build upon,” says Jamie Love of Knowledge Ecology International, a non-profit group that tracks access to medicines issues.

“While it is too soon to know if this prescription transparency legislation will continue to expand this year,” says Richard Cauchi, the program director for health insurance, financing and pharmaceuticals at the National Conference of State Legislatures, “state legislators often do look at what their colleagues in other states are doing.”

Most hospitals don’t have good ways of measuring the complex costs associated with an individual patient’s stay in the hospital. The VA is one surprising exception.

The success of health reform in the US depends on finding ways to control the growth of costs. Hospital care is expensive. And when patients have to be readmitted unexpectedly after discharge, it can really crank up spending.

As we strive to keep health care costs in line, reducing hospital readmissions is drawing a lot of attention. Reducing preventable readmissions could reduce health care spending and improve quality of care at the same time.

But very little research on readmission costs has been done. An exception is a study that found that one in five elderly Medicare patients is readmitted to the hospital within 30 days of being discharged, at an estimated cost of $17.4 billion in 2004.

Most hospitals don’t have good ways of measuring the complex costs associated with an individual patient’s stay in the hospital.

But there is, however, a hospital system that does a very good of job of tracking these costs: the Veterans Health Administration.

Veterans Affairs could provide a blueprint

The Veterans Health Administration (the VA) operates 119 acute care hospitals across the US, and has created an unparalleled comprehensive patient-cost accounting system, its Decision Support System (DSS).

The DSS works from the bottom up by summing the individual resources and costs each individual patients winds up needing during their hospital stay. Unlike most other hospital accounting systems, the VADSS also can separate costs that are fixed regardless of the volume of services provided, such as administrative overhead, from costs that vary with service volume, such as lab tests or imaging. All of this means that the VA can track patients’ costs with greater precision than most hospitals, and can more easily see the cost of readmissions.

There are other reasons why VA is a good setting for studying readmission costs. VA hospitals have a simpler set of incentives around readmitting patients. Under Medicare, hospitals face a trade-off between receiving payments for readmitting Medicare patients and avoiding payment penalties for not readmitting patients under the new ACA regulations.

But in the VA system, budgets are set annually, so there is no financial incentive to readmit patients. It will not increase the amount of money VA hospitals get. And physicians who work in VA hospitals are salaried VA employees. They do not gain financially when they readmit patients, so they have no incentive to provide unnecessary care.

How much money does preventing readmission save?

In a recent study, Theodore Stefos and I used 2011 Decision Support System data to examine the component of cost that varies with a readmission, to provide hospital managers with a more realistic estimate of how much they could save by reducing readmissions.

We found that managers could expect to save $2,140 for the average 30-day readmission prevented. For heart attack, heart failure, and pneumonia patients, expected readmission cost estimates were higher: $3,432, $2,488 and $2,278 respectively.

We also found that patients’ risk of illness was the main driver of expected readmission cost. This is an important finding for managers. Even though this is a factor they cannot control, they can expect that patients with a greater risk of illness might be at greater risk after controlling for other factors such as age. Men also were much more likely to be readmitted than women, as were lower income and unmarried vets. Understanding this information can help hospital managers better predict which patients are at risk for readmission, and to take steps to address this proactively.

While the VA has some processes of care that differ from other health care systems, its experience has important lessons for private sector hospitals, especially for those that treat a high share of chronically ill or low-income patients.

Why it is important to know what readmissions cost

Today hospitals are under increasing pressure to curb readmissions. For instance in 2013 Centers for Medicare & Medicaid Services (CMS) started to financially penalize hospitals for 30-day readmissions that exceed national averages for heart attack, heart failure and pneumonia. As of October 2014, chronic obstructive pulmonary disorder and elective knee and hip replacements are also being targeted and the penalty has increased up to 3% of the total Medicare reimbursement to the hospital.

Hospital managers would like to know what actual cost savings are when a readmission is avoided, so they can understand how readmissions affect their overall budgets.

The Centers for Medicare & Medicaid Services has paid out nearly $30 billion in meaningful use incentives for hospitals and physicians to adopt EHRs. But some members of Congress, the body that approved those funds, are about as frustrated with EHRs as doctors and nurses.

“The evidence suggests these goals haven’t been reached,” said Senator Lamar Alexander, R-Tennessee, in a long EHR hearing followed by Erin McCann, Healthcare IT News managing editor.

Robert Wergin, MD, president of the American Academy of Family Physicians, said that family physicians are having a difficult time with the Stage 2 meaningful use requirements. The “time, expense and effort it takes makes it not worth while,” said Wergin. Indeed, some 55 percent of physicians surveyed plan on skipping Stage 2 all together.

“The issue of interoperability between electronic health records represents one of the most complex challenges facing the healthcare community,” said Wergin. The government “must step up efforts to require interoperability.”

A central problem, as McCann wrote, is that “Vendors have no incentive to share data and create more interoperable systems. There’s the question of data ownership here. There’s the question of competition. And there’s the question of standards, or lack thereof.”

“The vendors are siloed,” as Wergin said. “And you’re held somewhat hostage by the vendor you have.”

U.S. Surgeon General Vice Admiral Vivek H. Murthy meets with Dr. Jonathan Woodson, assistant secretary of Defense for Health Affairs, at the Pentagon on March 11, 2015, to discuss the Military Health System’s critical role in support of the National Health Strategy.

eaders of the Military Health System met with the newly confirmed U.S. Surgeon General at the Pentagon on March 11. Dr. Jonathan Woodson, assistant secretary of Defense for Health Affairs, and Air Force Lt. Gen. Douglas Robb, director of the Defense Health Agency, discussed military health and the MHS’ critical role in support of the National Health Strategy in their first meeting with Vice Admiral Vivek H. Murthy since his confirmation by the U.S. Senate in December 2014.

“Our partnership with the Public Health Service has been instrumental in helping the Department and the Military Health System achieve its mission,” said Woodson. “Public Health Service officers have worked side-by-side with us in our military hospitals and clinics, in our laboratories, in support of our global health mission, and as part of the medical team serving all of our beneficiaries. One of the most prominent areas where we have collaborated is on implementation of health prevention and wellness initiatives. I look forward to continuing to work in close partnership with Admiral Murthy to promote health and healthy behaviors for our force and all of our beneficiaries.”

The meeting gave the leaders the important opportunity to discuss the Military Health System as a strategic asset in support of national security objectives, and the important role DoD plays in supporting the National Health Strategy, especially in areas such as reducing obesity and tobacco use.

“Our military medical personnel are all members of the larger federal team focused on improving the health and wellness of the entire country,” said Robb. “I am privileged to have Public Health Service officers working with me in the Defense Health Agency on a number of critical health matters. We’re one team engaged in one fight. It was a great opportunity to show Admiral Murthy everything we have to offer, and to express our appreciation for the talented people the Public Health Service shares with us.”

“Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”

— President Barack Obama, State of the Union Address, January 20, 2015

President Obama has long expressed a strong conviction that science offers great potential for improving health. Now, the President has announced a research initiative that aims to accelerate progress toward a new era of precision medicine (www.whitehouse.gov/precisionmedicine). We believe that the time is right for this visionary initiative, and the National Institutes of Health (NIH) and other partners will work to achieve this vision.

The concept of precision medicine — prevention and treatment strategies that take individual variability into account — is not new1; blood typing, for instance, has been used to guide blood transfusions for more than a century. But the prospect of applying this concept broadly has been dramatically improved by the recent development of large-scale biologic databases (such as the human genome sequence), powerful methods for characterizing patients (such as proteomics, metabolomics, genomics, diverse cellular assays, and even mobile health technology), and computational tools for analyzing large sets of data. What is needed now is a broad research program to encourage creative approaches to precision medicine, test them rigorously, and ultimately use them to build the evidence base needed to guide clinical practice.

The proposed initiative has two main components: a near-term focus on cancers and a longer-term aim to generate knowledge applicable to the whole range of health and disease. Both components are now within our reach because of advances in basic research, including molecular biology, genomics, and bioinformatics. Furthermore, the initiative taps into converging trends of increased connectivity, through social media and mobile devices, and Americans’ growing desire to be active partners in medical research.

Oncology is the clear choice for enhancing the near-term impact of precision medicine. Cancers are common diseases; in the aggregate, they are among the leading causes of death nationally and worldwide, and their incidence is increasing as the population ages. They are also especially feared, because of their lethality, their symptoms, and the often toxic or disfiguring therapies used to treat them. Research has already revealed many of the molecular lesions that drive cancers, showing that each cancer has its own genomic signature, with some tumor-specific features and some features common to multiple types. Although cancers are largely a consequence of accumulating genomic damage during life, inherited genetic variations contribute to cancer risk, sometimes profoundly. This new understanding of oncogenic mechanisms has begun to influence risk assessment, diagnostic categories, and therapeutic strategies, with increasing use of drugs and antibodies designed to counter the influence of specific molecular drivers. Many targeted therapies have been (and are being) developed, and several have been shown to confer benefits, some of them spectacular.2 In addition, novel immunologic approaches have recently produced some profound responses, with signs that molecular signatures may be strong predictors of benefit.3

These features make efforts to improve the ways we anticipate, prevent, diagnose, and treat cancers both urgent and promising. Realizing that promise, however, will require the many different efforts reflected in the President’s initiative. To achieve a deeper understanding of cancers and discover additional tools for molecular diagnosis, we will need to analyze many more cancer genomes. To hasten the adoption of new therapies, we will need more clinical trials with novel designs4 conducted in adult and pediatric patients and more reliable models for preclinical testing. We will also need to build a “cancer knowledge network” to store the resulting molecular and medical data in digital form and to deliver them, in comprehensible ways, to scientists, health care workers, and patients.

The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in “precision oncology”: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means for monitoring responses and tumor recurrence, and limited knowledge about the use of drug combinations.

Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace, the successful staples of oncology — prevention, diagnostics, some screening methods, and effective treatments — while providing a strong framework for accelerating the adoption of precision medicine in other spheres. The most obvious of those spheres are inherited genetic disorders and infectious diseases, but there is promise for many other diseases and environmental responses.

The initiative’s second component entails pursuing research advances that will enable better assessment of disease risk, understanding of disease mechanisms, and prediction of optimal therapy for many more diseases, with the goal of expanding the benefits of precision medicine into myriad aspects of health and health care.

The initiative will encourage and support the next generation of scientists to develop creative new approaches for detecting, measuring, and analyzing a wide range of biomedical information — including molecular, genomic, cellular, clinical, behavioral, physiological, and environmental parameters. Many possibilities for future applications spring to mind: today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose, blood pressure, and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases; fecal sampling might identify patterns of gut microbes that contribute to obesity; or blood tests might detect circulating tumor cells or tumor DNA that permit early detection of cancer or its recurrence.

Such innovations will first need to be tested in pilot studies. We will initially want to take advantage of the rare settings where it is already possible to collect rich information through clinical trials, electronic medical records, and other means.

Ultimately, we will need to evaluate the most promising approaches in much larger numbers of people over longer periods. Toward this end, we envisage assembling over time a longitudinal “cohort” of 1 million or more Americans who have volunteered to participate in research. Participants will be asked to give consent for extensive characterization of biologic specimens (cell populations, proteins, metabolites, RNA, and DNA — including whole-genome sequencing, when costs permit) and behavioral data, all linked to their electronic health records. Qualified researchers from many organizations will, with appropriate protection of patient confidentiality, have access to the cohort’s data, so that the world’s brightest scientific and clinical minds can contribute insights and analysis. These data will also enable observational studies of drugs and devices and potentially prompt more rigorous interventional studies that address specific questions.

Such a varied array of research activities will propel our understanding of diseases — their origins and mechanisms, and opportunities for prevention and treatment — laying a firm, broad foundation for precision medicine. It will also pioneer new models for doing science that emphasize engaged participants and open, responsible data sharing. Moreover, the participants themselves will be able to access their health information and information about research that uses their data.

The research cohort will be assembled in part from some existing cohort studies (many funded by the NIH) that have already collected or are well positioned to collect data from participants willing to be involved in the new initiative. Creating this resource will require extensive planning to achieve the appropriate balance of participants, develop new approaches to participation and consent, and forge strong partnerships among existing cohorts, patient groups, and the private sector. It will also be crucial to carefully examine the successes and shortfalls of other longitudinal cohort studies.

Achieving the goals of precision medicine will also require advancing the nation’s regulatory frameworks. To unleash the power of people to participate in research in innovative ways, the NIH is working with the Department of Health and Human Services to bring the Common Rule, a decades-old rule originally designed to protect research participants,5 more in line with participants’ desire to be active partners in modern science. To help speed the translation of such discoveries, the Food and Drug Administration is working with the scientific community to make sure its oversight of genomic technology supports innovation, while ensuring that the public can be confident that the technology is safe and effective.

Although the precision medicine initiative will probably yield its greatest benefits years down the road, there should be some notable near-term successes. In addition to the results of the cancer studies described above, studies of a large research cohort exposed to many kinds of therapies may provide early insights into pharmacogenomics — enabling the provision of the right drug at the right dose to the right patient. Opportunities to identify persons with rare loss-of-function mutations that protect against common diseases may point to attractive drug targets for broad patient populations. And observations of beneficial use of mobile health technologies may improve strategies for preventing and managing chronic diseases.

Ambitious projects like this one cannot be planned entirely in advance; they should evolve in response to scientific and medical findings. Much of the necessary methodology remains to be invented and will require the creative and energetic involvement of biologists, physicians, technology developers, data scientists, patient groups, and others. The efforts should ideally extend beyond our borders, through collaborations with related projects around the world. Worldwide interest in the initiative’s goals should motivate and attract visionary scientists from many disciplines.

This initiative will also require new resources; these should not compete with support of existing programs, especially in a difficult fiscal climate. With sufficient resources and a strong, sustained commitment of time, energy, and ingenuity from the scientific, medical, and patient communities, the full potential of precision medicine can ultimately be realized to give everyone the best chance at good health.